A Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects - Full Text View

Sponsored by:	Regeneron Pharmaceuticals
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00856310

Purpose

This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.

Condition	Intervention	Phase
Healthy	Drug: REGN475	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Serum concentrations of REGN475. [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
The presence or absence of antibodies against REGN475. [ Time Frame: 16 Week follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	February 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Active Comparator 0.1 mg/kg REGN475	Drug: REGN475 Biological / Vaccine
Cohort 2: Active Comparator 0.3 mg/kg of REGN475	Drug: REGN475 Biological / Vaccine
Cohort 3: Active Comparator 0.03 mg/kg of REGN475	Drug: REGN475 Biological / Vaccine
Cohort 4: Active Comparator 1.0 mg/kg of REGN475	Drug: REGN475 Biological / Vaccine
Cohort 5: Active Comparator 3.0 mg/kg of REGN475	Drug: REGN475 Biological / Vaccine
Cohort 6: Active Comparator 0.1 mg/kg REGN475 subcutaneous administration	Drug: REGN475 Biological / Vaccine
Cohort 7: Active Comparator 0.3 mg/kg REGN475 subcutaneous administration	Drug: REGN475 Biological / Vaccine

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Key Inclusion Criteria:

Male or female volunteers, in general good health and 21 to 65 years of age.
Female volunteers must be post-menopausal for at least 1 year or surgically sterile.

Key Exclusion Criteria:

Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856310

Contacts

Contact: Chiwoniso Kaminski

610-505-5573

chiwoniso.kaminski@regeneron.com

Locations

United States, Pennsylvania
	Recruiting
Confidential, Pennsylvania, United States

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director:

Paul Tiseo, PhD

Regeneron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Regeneron Pharmaceuticals ( Paul Tiseo, PhD/ Medical Director )
Study ID Numbers:	R475-PN-0817
Study First Received:	February 12, 2009
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00856310 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:

Healthy volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009